# IVOS Medical: Intubation, Optimized.

> **NIH NIH R44** · IVOS MEDICAL, INC. · 2024 · $824,627

## Abstract

Abstract
Endotracheal intubation is a critical, life-saving procedure, and every second counts. While the process of
endotracheal intubation is common, it is still considered a high-risk procedure performed globally. In the US
alone, there are 15M operating room intubations and over 1.5M critically ill adults intubated in settings outside
of an operating room each year. Failure to intubate the trachea (wind pipe) on the first attempt occurs in 20 to
30% of tracheal intubations performed in the emergency department (ED) or intensive care unit (ICU) and is
associated with an increased risk of life-threatening complications. Introduced in the early 2000s, video
laryngoscopy was developed to assist with difficult intubation, as an alternative to the traditional practice of
direct laryngoscopy. The video laryngoscope functions by means of a video camera situated at the distal end of
the laryngoscope blade. This blade is inserted into a disposable plastic `sleeve' to prevent cross-contamination
of bodily fluids and promote camera cleanliness during the endotracheal intubation procedure. When inserted
into the mouth, it provides an indirect view of the vocal cords on a separate monitor. This tool, widely utilized
for airway visualization, has gained increasing acceptance as a first-line intervention for intubation in
emergency scenarios. The current problem with video laryngoscopy, like any camera lens, is that the visual
field can become obscured when bodily fluids or solids adhere to its external surface. This issue is among the
most common causes for failed intubation in pre-hospital, EDs, and ICU settings. During an intubation
procedure, the operator must suction away bodily fluids with a separate suction catheter and often physically
remove the scope from the mouth to wipe the external camera lens clean. This occurs while the patient is not
breathing and potentially becoming increasingly hypoxic. Research indicates that the failure rate escalates to
60-75% by the third intubation attempt, underscoring the critical importance of securing the breathing tube on
the first attempt. IVOS Medical is a device company developing an improved video laryngoscope sleeve
named the Breathing Optimization and Suction System (BOSS) G4. The BOSS G4 is a single-use, one-piece,
sleeve, designed to fit over existing video laryngoscope camera systems. When tested on our controlled
vomiting manikin among 54 airway specialists, the BOSS G4 demonstrated statistically faster intubation by
securing the airway 12 seconds quicker, reduction in measured pulmonary aspiration by 37 mL, and achieving
a first-pass success rate of 98%. The goal of this Phase II research proposal is to continue Phase I
development and manufacture clinical-ready units under Good Manufacturing Practice, conduct a preclinical
study using human cadavers, and conclude with an in-human feasibility trial at the University of California,
Irvine Medical Center. Successful completion of this NIH SBIR Phase II,...

## Key facts

- **NIH application ID:** 10922562
- **Project number:** 2R44HL164325-02
- **Recipient organization:** IVOS MEDICAL, INC.
- **Principal Investigator:** Gabriel Punsalan
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $824,627
- **Award type:** 2
- **Project period:** 2022-04-01 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10922562

## Citation

> US National Institutes of Health, RePORTER application 10922562, IVOS Medical: Intubation, Optimized. (2R44HL164325-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10922562. Licensed CC0.

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